A Multi-Center Post-Market Retrospective Data Collection Protocol to Evaluate the Real World Performance of Orthofix Spine Stim Devices Compared to Control
A Multi-Center Post-Market Retrospective Data Collection Protocol to Evaluate the Real World Performance of Orthofix Spine Stim Devices Compared to Control
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Clinical Trial Information
Trial Contact: Carlo, Charlene S; Monserrate, Francheska
Trial Phone: 321.841.1324 ; 321-841-4717
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IRB No: 22.097.04
Protocol Abbrev: Spine Stim
Principal Investigator: Virgilio Matheus, MD, FACS
Age Group: Adult
Secondary Protocol No: CP-2201SSCS
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Objective
This protocol is designed to study Orthofix’ regulatory approved and commercially-available spine stimulation devices in the applicable geography to generate Real World Evidence (RWE) of device performance data and use in the treatment and follow-up of patients with cervical or lumbar spinal fusion following the local medical standard of care.
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Key Eligibility
Patients using Orthofix stimulation devices following cervical or lumbar spinal fusion
